510(k) K033234 ยท DHA System, Test, Human Chorionic Gonadotropin
IMMULITE 2500 AUTOMATED IMMUNOASSAY ANALYZER
| Applicant | Diagnostic Products Corp., Los Angeles CA, US |
| Decision | Substantially Equivalent, Dec 12, 2003 |
| Received | Oct 6, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K033234
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 10, 2010 | Siemens Healthcare Diagnostics Inc. IMMULITE 2000 and IMMULITE 2500
IgG/IgM Sample Diluent, Cat. No. L2IGZ2, Lot Number 150 Terminated |
LFX | None listed |
| May 26, 2009 | Siemens Medical Solutions Diagnostics Immulite 2000 and Immulite 2500 digital Fluidics PC Board,
Part Number 450116-0002.
Performs chemiluminescent immunoassays using serum, plasma, and/or urine for in vitro diagnostic testing. Terminated |
DGC | None listed |
| Nov 30, 2004 | DPC Cirrus Immulite 2500 Automated Immunoassay Analyzer, Human chorionic gonadotrpin (HCG) test system. Terminated |
DHA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.